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Physicians’ perspectives regarding pragmatic clinical trials [PDF]

Journal of Comparative Effectiveness Research, 2016
Aim: Practicing physicians inevitably become involved in pragmatic clinical trials (PCTs), including comparative effectiveness research. We sought to identify physicians’ perspectives related to PCTs. Methods: In-depth semistructured interviews with 20 physicians in the USA. Results:
Rachel, Topazian, Juli, Bollinger, Kevin P, Weinfurt, Rachel, Dvoskin, Debra, Mathews, Kathleen, Brelsford, Matthew, DeCamp, Jeremy, Sugarman   +7 more
openaire   +2 more sources

Pragmatic Problems With Clinical Equipoise

, 2010
It is widely accepted that if one is to follow the ethical tenets of clinical equipoise, phase III controlled clinical trials must be designed pragmatically, to measure effectiveness rather than efficacy.
Kowalski, Charles J
core   +1 more source

The efficacy-effectiveness distinction in trials of alcohol brief intervention. [PDF]

, 2014
Three recent sets of null findings from trials of alcohol brief intervention (BI) have been disappointing to those who wish to see a reduction in alcohol-related harm through the widespread dissemination of BI.
Nick Heather, Heather, Nick
core   +1 more source

Pros and cons of pragmatic clinical trials

Journal of Comparative Effectiveness Research, 2013
Traditional randomized controlled trials are the ‘gold standard’ for evaluating health interventions and are typically designed to maximize internal validity, often at the cost of limited generalizability. Pragmatic randomized controlled trials should be designed with a conscious effort to generate evidence with a greater external validity by making ...
Jon D, Lurie, Tamara S, Morgan
openaire   +2 more sources

The need for increased pragmatism in cardiovascular clinical trials

Nature Reviews Cardiology, 2022
The majority of cardiovascular randomized controlled trials (RCTs) test interventions in selected patient populations under explicitly protocol-defined settings. Although these 'explanatory' trial designs optimize conditions to test the efficacy and safety of an intervention, they limit the generalizability of trial findings in broader clinical ...
Muhammad Shariq Usman, Harriette G. C. Van Spall, Stephen J. Greene, Ambarish Pandey, Darren K. McGuire, Ziad A. Ali, Robert J. Mentz, Gregg C. Fonarow, John A. Spertus, Stefan D. Anker, Javed Butler, Stefan K. James, Muhammad Shahzeb Khan   +12 more
openaire   +4 more sources

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

BMC Medical Research Methodology, 2017
Background The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care ...
Kevin P. Weinfurt, Adrian F. Hernandez, Gloria D. Coronado, Lynn L. DeBar, Laura M. Dember, Beverly B. Green, Patrick J. Heagerty, Susan S. Huang, Kathryn T. James, Jeffrey G. Jarvik, Eric B. Larson, Vincent Mor, Richard Platt, Gary E. Rosenthal, Edward J. Septimus, Gregory E. Simon, Karen L. Staman, Jeremy Sugarman, Miguel Vazquez, Douglas Zatzick, Lesley H. Curtis   +20 more
doaj   +1 more source

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery

Trials, 2023
Introduction Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems.
Mark R. Edwards, Gordon Forbes, Neil Walker, Dion G. Morton, Monty G. Mythen, Dave Murray, Iain Anderson, Borislava Mihaylova, Ann Thomson, Matt Taylor, Marianne Hollyman, Rachel Phillips, Keith Young, Brennan C. Kahan, Rupert M. Pearse, Michael P. W. Grocott, for the FLO-ELA investigators   +16 more
doaj   +1 more source

Ethics and Collateral Findings in Pragmatic Clinical Trials [PDF]

The American Journal of Bioethics, 2020
Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research ...
Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra JH Mathews, Jeremy Sugarman   +5 more
openaire   +2 more sources

Early Body Mass Index z‐Score Change and Resolution of Severe Malnutrition in Children With Sickle Cell Anemia in a Low‐Income Setting: A Prospective Single‐Arm Extension Study

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Children with sickle cell anemia (SCA) in low‐income settings are at risk of severe malnutrition, but optimal nutritional management has not been established. We evaluated an intensified ready‐to‐use therapeutic food (RUTF) regimen in children with persistent severe malnutrition after initial treatment and assessed whether early ...
Safiya Gambo, Shehu Umar Abdullahi, Hassan Adam Murtala, Halima Kabir, Khadija A. Shamsu, Sari A. Acra, Virginia A. Stallings, Mark Rodeghier, Michael R. DeBaun, Lauren J. Klein   +9 more
wiley   +1 more source

Pragmatic Clinical Trials in CKD: Opportunities and Challenges [PDF]

Journal of the American Society of Nephrology, 2016
Randomized controlled trials in CKD lag in number behind those of other chronic diseases, despite the high morbidity and mortality experienced by patients with kidney disease and the exorbitant costs of their health care. Observational studies of CKD frequently yield seemingly paradoxic associations of traditional risk factors with outcomes, making it ...
Ian H, de Boer, Csaba P, Kovesdy, Sankar D, Navaneethan, Carmen A, Peralta, Delphine S, Tuot, Miguel A, Vazquez, Deidra C, Crews   +6 more
openaire   +2 more sources